NCT01399853View on ClinicalTrials.gov

A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

November 30, 2011

Study Completion Date

May 31, 2012

Conditions
ImmunogenicitySafety
Interventions
BIOLOGICAL

160U /0.5ml EV71 Vaccine

inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval

BIOLOGICAL

320U /0.5ml EV71 vaccine

inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval

BIOLOGICAL

640U /0.5ml EV71 vaccine

inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval

BIOLOGICAL

(without adjuvant) 640U /0.5ml

inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval

BIOLOGICAL

0/0.5ml placebo

0/0.5ml placebo, two doses, 28 days interval

Trial Locations (1)

210009

Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing

All Listed Sponsors
collaborator

Bejing Vigoo Biological Co., LTD

INDUSTRY

lead

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

NCT01399853 - A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants | Biotech Hunter | Biotech Hunter